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FDA to Weigh Options for Importing Single-Source Drugs
Drugs Regulatory Affairs
FDA Commissioner Scott Gottlieb announced that the agency will consider allowing imports of some drugs that have seen major price increases in the United States.
The circumstances could include sudden, major price increases that “close off channels of availability” such as a sudden increase in the cost of an older generic with only one version on the market.
Gottlieb said a working group will study how the agency would deem an access issue serious enough to require importation and ways to ensure safety and quality of imported drugs.